Semi-Automatic Aerosol Filler for Spanish Oral Spray — AEMPS Health Supplement
Farmacia Spray Labs S.L., Spain
Industry
Health Supplement · Oral Aerosol
Video Reference
Factory FAT and commissioning review
HEMUfill factory video for equipment build quality, FAT workflow and remote commissioning context. Customer-specific site videos can be added when approved footage is available.
Challenge
Spanish pharmaceutical supplement company required a semi-automatic aerosol filler for 30ml metered-dose oral spray (propolis, vitamin D3, melatonin) — AEMPS food supplement notification, EU Regulation 1169/2011 nutrition labelling on small 30ml bottle, metered-dose valve (100µl ±5% per actuation), pharmaceutical-grade ethanol propellant with USP certificate and COA traceability and child-resistant cap press-fit.
Results
- ✓AEMPS food supplement notification: 3 oral spray products approved for Spain
- ✓100µl ±5% metered-dose valve: dose uniformity validated per Ph. Eur. 2.9.44
- ✓EU 1169/2011 nutrition labelling on 30ml bottle: approved by AECOSAN reviewer
- ✓Child-resistant cap: EN ISO 8317 child-resistant closure certification
- ✓Amazon Spain + El Corte Inglés pharmacy: market entry within 4 months
Application Review Note
Semi Automatic Aerosol Filling Machine application · Spain · configuration reference
